The present invention relates to nasal oxygen cannula technology. More specifically, the present invention pertains to devices and methods especially configured and adapted to stabilize and increase the retention of nasal oxygen cannulas while increasing the comfort of wearing same.
Nasal oxygen cannulas are utilized to deliver oxygen directly to nasal airways in order to infuse oxygen into the inspirational air flow of patients in need of such therapy. Typically, these systems utilize a relatively large bore plastic supply tube as a conduit for providing gas flow from a pressurized oxygen source to proximal ends of a pair of plastic oxygen delivery tubesxe2x80x94having relatively smaller boresxe2x80x94. The pair of oxygen delivery tubes are ordinarily equal in length. The distal portions of the delivery tubes, conventionally, enter into opposite ends of a short, expanded piece of plastic tubing, referred to as an oxygen delivery barrel. Thus the oxygen delivery barrel acts to join and form a loop between the two oxygen supply tubes thereby providing a junction. The barrel is typically cylindrical in shape, formed of a short length of enlarged plastic tubing provided with small diameter, stub like extensions known as oxygen delivery stubs. The stubs are open at their distal ends and are positioned in circumferential alignment upon the barrel and at right angles,xe2x80x94or transversexe2x80x94to the longitudinal axis of the barrel. The oxygen delivery stubs are positioned so that the distance there between approximates an average distance between the nostrils in which they will be positioned.
The bores of the oxygen supply tube, oxygen delivery tubes, oxygen supply barrel and delivery stubs are in fluid communication. Therefore, oxygen flowing from a pressurized oxygen source to the proximal end of the supply tube will flow through the supply tube and then on to the delivery tubes which will conduct the oxygen to the delivery barrel. As pressurized oxygen fills the barrel, oxygen will flow out from the stubs and into the nostrils of an individual in which the stubs are positioned. Thereafter, the patients own inspirational air flow will assist entry of the oxygen supplied by the catheter/cannula through the respiratory tract and into the lungs.
In order to properly provide oxygen delivery to a patient, oxygen catheter/cannulas must be maintained in a position wherein the delivery stubs are aligned with and retained within each of a patients nostrils. Conventional catheter/cannulas have largely depended upon the use of the pair of oxygen delivery tubes, connected to each end of the barrel, to stabilize the barrels position under the nose and thereby assist in maintaining the position of the oxygen delivery stubs within the patient""s nostrils. By looping each of two delivery tubes over the top of each ear, a portion of the tube becomes trapped in the skin folds between the ear and the skin of the head medial thereto. The tension provided by trapping the tubes under the ear, prevents free movement of the delivery tubes and thus provides stabilization of the oxygen delivery barrel under and delivery stubs under a user""s nose and within a user""s nostrils.
Proximal to the ear foldsxe2x80x94relative to the oxygen supplyxe2x80x94the pair of delivery tubes junction with the larger diameter supply tube under the patients head. Alternatively, the delivery tubes may pass behind the ears, around the neck and under the patients chin where the tubes junction with the single supply tube.
The above-described method and apparatus does provide, in some circumstances, for limited oxygen cannula stabilization. In fact, utilizing the above-described conventional oxygen cannula without an ear loop will ordinarily result in rapid displacement of the delivery stubs upon movement of the patient""s head. However, there are also many disadvantages and limitations related to utilizing this conventional apparatus and method. For example, patients do tend to move their heads during sleep. Therefore, there is an associated movement of the pair of oxygen delivery tubes looped behind the ears. Movement of these tubes often causes irritation, abrasion and pain arising from friction at the skin folds between the ear and head. As a result of such pain, patients often xe2x80x9cshake offxe2x80x9d the catheter/cannula in during the restless and interrupted sleep caused thereby. The frequent loss of the oxygen delivery stubs from the patients nostrils caused by shake off and displacement deprives the patient of required consistent oxygen therapy. In light of the current nursing shortage, the constant checking and supervision required by such an unreliable and high maintenance stabilization means is highly undesirable and, more importantly, ineffective. In addition, the afore-mentioned abrasion and irritation tend to interfere with patient rest as well as increasing the possibility that the catheter/cannula will be removed before adequate oxygen therapy is provided. The terms xe2x80x9cnasal catheter/cannulaxe2x80x9d, xe2x80x9cnasal cannulaxe2x80x9d, xe2x80x9cnasal oxygen catheter/cannulaxe2x80x9d and xe2x80x9cnasal oxygen cannulaxe2x80x9d as utilized throughout this specification and within the claims are interchangeable and refer, collectively and individually to a device comprised of an oxygen supply delivery, oxygen delivery tube, an oxygen supply barrel and nasal stubs utilized to provide oxygen delivery and/or enrichment therapy to a user by delivering oxygen directly to a user""s external nasal airways.
U.S. Pat. No. 6,093,169 (the xe2x80x9c169 patentxe2x80x9d) addresses, to some extent, the above-described catheter/cannula positioning/retention problems. In order to improve retention of the nasal oxygen delivery stubs within the nostrils, the ""169 patent discloses the use of a detachable retainer which is positioned along the ridge pole of the nose. The ridge pole retainer, defining what may be described as an xe2x80x9cLxe2x80x9d shaped strut, has a long xe2x80x9clegxe2x80x9d and a short xe2x80x9clegxe2x80x9d. The long leg of the strut is configured and adapted to generally conform to and lie upon the ridge pole of the nose from the root of the nose to an area proximate to the tip of the nose. The strut is comprised of a flexible material such as a plastic or fabric covered/padded metal framework. They may be secured to the ridge pole of the nose with a suitable adhesive means such as, for example, external tape or a self-adhesive backing. The short leg of the strut lies in an angular relationship with the long strut so that it may be positioned under the nose, generally in line with the nasal septum. In certain embodiments, a cup-shaped portion of the retainer, extending lateral to a junction of the long and short leg of the strut, is especially configured and adapted to capture the tip of the nose.
The short leg also includes, in certain preferred embodiments, a curved portion that is especially adapted and configured to pass around and securely hold an oxygen delivery barrel. The barrel is thus held and secured in a position and orientation that assures that delivery stubs arising therefrom remain well within a patients nostrils.
As described above, the device disclosed by the ""169 patent is advantageously comprised of a springy plastic or springy metal backbone demonstrating high elastic memory within operational limits. The backbone is advantageously covered with a soft fabric padding. The elastic memory of the device, in combination with the contour and elastic nature thereof, provides a traction force to the nose when the device is secured along the ridge pole of a patient""s nose. The device may be so secured by any suitable means including, for example, elastic strips or a self-adhesive backing. The traction force of the device, so applied and secured, tends to pull the tip of the wearer""s nose both upward and inward. More specifically, as the long arm of the retainer, contoured to approximate to the ridge pole is urged upward towards the root of the nose (due to its shape, spring tension and the effect of the adhesive strips and/or backing), the cup-shaped portion pulls the tip of the nose upward and inward towards the forehead. The pulling upward and inward of the tip of the nose, in turn, tends to shorten and increase the diameter of the external nasal airway as compared to bore status without the device. As a result, the external nasal bore, widened and shortened, provides decreased airway resistancexe2x80x94allows greater inspirationxe2x80x94and thus more efficient oxygen deliveryxe2x80x94. At the same time, the device provides great stabilization and retention to the oxygen delivery barrel and delivery stubs under the nose and within the nostrils.
Although the device described by the ""169 patent provides increased catheter/cannula stabilization, it is still utilized with the above-described ear loops in order to further stabilize the device. Thus, although greater stability is provided by the cannula support device described therein, a patient is still at risk for the irritation, abrasion and resultant xe2x80x9cthrow offxe2x80x9d associated with such loops.
What is needed is a catheter/cannula device and method of utilizing same, which provides the increased stabilization and increased airway efficiency demonstrated by the ""169 patent, while, at the same time, eliminating the use of ear loops and the irritations and abrasions associated with the use thereof.
Now in accordance with the present invention, a nasal catheter/cannula support device is disclosed providing improved nasal catheter/cannula positioning while, at the same time, eliminating the need to utilize ear loops for the retention and stabilization thereof. In a first preferred embodiment of the present invention, a nasal catheter/cannula support device utilizes a ridge pole retainer to stabilize a nasal catheter/cannula. The ridge pole retainer of the present invention is comprised of a generally xe2x80x9cLxe2x80x9d-shaped strut having a long leg and a short leg. The long and short legs of the strut are in such an angular relation so as to allow the short leg to pass around and under the tip of the user""s nose when the long leg is aligned with the ridge pole region of the nose. Each of the embodiments of the present invention include an oxygen delivery tube management means associated with the long leg of the strut for positioning and retaining the delivery tube(s).
The long leg of the strut is advantageously shaped and configured so as to approximate nasal ridge pole contour. The strut is advantageously formed of a material with sufficient elastometric and elastic memory properties so as to allow the strut to be easily biased into intimate contact a ridge pole region of a patient""s nose, while at the same time, exerting force stored thereby, within the material urging the strut back to its original shape.
The short leg of the strut is continuous with and generally in an angular relationship with the long leg so as to generally pass around and under a patient""s nose when the long leg is in general alignment with the nasal ridge pole. A distalxe2x80x94or inferiorxe2x80x94portion of the short leg may advantageously include, in certain embodiments, a curved section especially configured and adapted for securing an oxygen delivery barrel in a functional position under a patients nose so that the nasal delivery stubs located on the barrel are held and maintained within a patient""s nostrils. Alternatively, a curved cup-shaped portion of the ridge pole retainer, extending laterally from the junction of the short and long legs, may be utilized to capture the nasal tip. The cup-shaped portion extends laterally so as to encompass the tip of the nose and may advantageously includes a plurality of finger-like extensions especially configured and adapted for securing an oxygen delivery barrel to the retainer device. The finger-like extensions also act to align the oxygen delivery stubs of the oxygen delivery barrel within patient""s nostrilsxe2x80x94also preventing rotation and other displacement of the stubs and barrelxe2x80x94.
The nasal catheter/cannula support device of the present invention includes a means of securing catheter/cannula delivery tubes thereto. More specifically, the ridge pole retainer includes a means for securing oxygen delivery tubes to the long leg of the strut so as to obviate the need to use ear loop retention. In certain embodiments of the present invention, adhesive is utilized to affix the delivery tubing to the long leg. For example, adhesive tape or adhesive bonding material may be utilized. In other embodiments, the long leg of the ridge pole retainer is provided with a plurality of finger-like projections having little to no elastic memory. The finger-like projections of the long leg are selected to demonstrate a diameter and length sufficient to allow said projections to be bent around, engage and stabilize delivery tubing upon the long leg of the retainer. Alternatively, the delivery tube(s) may be molded to (or fused) to the long leg when the long leg is comprised of a plastic material Alternatively other means of joining the delivery tubes, such as, for example, fabric having hook and loop fastening extensions means and nylon ties may also be advantageously selected.
In utilizing the support structure of the present invention, an oxygen supply barrel is positioned within the curved portion of the short legxe2x80x94or by means of the afore-mentioned finger-like projections of the cup-shaped portion of the strutxe2x80x94so that oxygen supply stubs located upon the barrel are positioned on either side of the long axis of the short leg and in a direction in general alignment with the long leg. The oxygen supply barrel is connected to and in fluid communication with a pair of oxygen delivery tubes which, in turn are connected to an oxygen supply tube and a pressurized oxygen source. The device is then positioned against a patient""s nose so that the long leg is biased into intimate contact with the nasal ridge pole thereof. At the same time, the device is also positioned so that the short leg curves around and under the tip of the nose. In embodiments of the present invention utilizing a cup-shaped region, said region is held in intimate contact with the tip of the user""s nose. The device is held in the afore-mentioned position by means, for example, such as adhesive tape placed along, and generally, perpendicular to the long leg. In other embodiments, the long leg may be provided with an adhesive backing. As the device, due to its elastic memory, attempts to regain an original, unbiased shape, the forces generated thereby tend to elevate and shorten the tip of the nose, in turn causing the external nasal airway to shorten and increase in bore. At the same time, the device, by means of the above-described curved portion of the short legsxe2x80x94and in certain embodiments, finger-like projections of the cup-shaped portionxe2x80x94retains the oxygen delivery barrel under the nose and the oxygen delivery stubs within the patient""s nostrils. As discussed in further detail below, certain embodiments of the present invention provide struts so closely shaped and adapted to the external surface contour of a user""s nose as to obviate the need for adhesive fixation of the strut to the nose.
In a first preferred embodiment of the present invention, the oxygen supply barrel is selected to be of a xe2x80x9cconventionalxe2x80x9d type, with fluid connection thereto provided at opposite ends of the delivery barrel as has been known to the prior art. Therefore, in practicing the first preferred embodiment of the present invention, a pair of oxygen delivery tubes, in fluid communication with opposite ends of the barrel, are looped up to, and brought in parallel contact, along the midline of the longitudinal axis of the long leg of the retainer. The delivery tubes, thus approximated and positioned, are then held in place along the retainer a securing means. The securing means may be advantageously selected to be, for example, a bonding agent, cement or adhesive tape. The securing means may also be selected to be retentive fabric demonstrating hook and loop fastening such as Velcro(TM) or nylon tie devices. In addition, small, pliable metal extensions may be provided upon the long leg so as to allow fixation of the delivery tubes in axial alignment with the strut. The loop produced by directing the oxygen delivery lines from the opposite ends of the oxygen supply barrel upward so as to join at the long leg of the retainer is relatively small and extends a small distance, lateral to the user""s nose, as compared to the ear loop of the prior art. The diminutive nature of the loop is of great importance as such small loops define relatively short lever arms. Thus, since the loops do not extend, substantially, laterally from the long axis of the nose and ridge pole retainer, movement of these loops results in diminutive displacement force transfer to and/or torsion of the catheter/cannula.
Above and beyond the ridge pole retainer, the delivery tubes are held together by means of adhesive. They may also be held together by any other suitable means such as, for example, fabric strips, adhesive tape, nylon ties, or elastic bands. It is also contemplated that the delivery tubes utilized in practicing the present invention may be formed together, from a point where the tubes meet and are held at the long leg of the retainer, until they junction with the oxygen supply tube. In all such embodiments, the tubing is directed over the patients forehead where it junctions with the supply tube above and behind the patient. Thus, the first preferred embodiment of the present invention, as all embodiments thereof, avoid the use of ear loops for catheter/cannula stabilization and retention.
In a second preferred embodiment of the present invention, the oxygen supply barrel is provided having oxygen delivery tube connections located at opposite ends thereof. However, unlike oxygen delivery barrels of the prior art, the oxygen barrel utilized in practicing the second preferred embodiment of the present invention provides delivery line entry into the barrel at right angles to the long axis thereof. The entry of the delivery tubes into the delivery barrel may be advantageously selected to be in substantial circumferential alignment with the nasal oxygen delivery stubs thereof so that the delivery tubes, as discussed below, may be guided towards the ridge pole and long leg of the retainer to which said tubes are affixedxe2x80x94with a minimum of curvature and/or turns required therefore. The delivery tubes, which are in fluid communication with the barrel, may be connected to the barrel via right angle fittings located at opposite ends or proximate opposite ends of the barrel. In the alternative, the barrel utilized in practicing the second preferred embodiment of the present invention may incorporate, as an integral feature, delivery tubes entering the barrel at the afore-mentioned right angle orientation which are fused and/or molded to the oxygen delivery barrel. Therefore, as the delivery tubes exit the oxygen supply barrel, a minimum of looping or lateral excursion of the tubes is necessary in order for the tubes to meet and be affixed along the midline of the long leg. Only a slight curvature towards the long axis of the retainer is required in order to align the tubing therewith. As in the case of the first embodiment, the tubing may be affixed to the long leg by any suitable means such as, for example, a bonding agent, cement or adhesive tape. The securing means may also be selected to be retentive fabric such as Velcro(TM) or nylon tie devices . In addition, small, pliable metal extensions may be provided upon the long leg so as to allow fixation of the delivery tubes in axial alignment with the strut. The second preferred embodiment avoids the required ear loop of the prior art as well as the diminutive loop produced in utilizing the device and practicing the method of the first preferred embodiment herein. The second preferred embodiment does require that delivery tubing run lateral to the midline of the ridge pole and retainer. However, the lever arm produced by such diminutive lateral placement allows little if any translation of head movementxe2x80x94and resultant movement of delivery lines, into torsional or other displacement forces that would otherwise act to dislodge or disturb catheter/cannula placement.
As in the case of the first preferred embodiment, above and beyond the ridge pole retainer, the delivery tubes are held together by a suitable means such as, for example, an adhesive. They may also be held together by any other suitable means such as, for example, fabric strips, adhesive tape, nylon ties or elastic bands. It is also contemplated that the delivery tubes utilized in practicing the present invention may be formed together, from a point where the tubes meet and are held at the long leg of the retainer, until they junction with the oxygen supply tube. In all such embodiments, the tubing is directed over the patients forehead where it junctions with the supply tube above and behind the patient. Thus, the second preferred embodiment of the present invention, like all embodiments thereof, avoid the use of ear loops for catheter/cannula stabilization and retention.
In the third preferred embodiment of the present invention, an oxygen supply barrel is provided having an oxygen delivery tube connection located approximately at the middle of the length thereof. The delivery line connection is oriented so as to be transverse to, and approximately midway between the ends of the oxygen delivery barrel. Therefore, the oxygen delivery tube is positioned on the barrel in such a manner that it may be affixed to the long leg of the retainer with only a minimum of curvature and substantially no lateral extension. The oxygen supply barrel of the third preferred embodiment may be provided with a tube fitting for receipt of the single oxygen delivery tube utilized thereby, or, in the alternative, the barrel may incorporate an integral delivery tube located at the afore-mentioned midline position with the oxygen delivery stubs being located lateral to, and on either side of the tube. Unlike oxygen delivery barrels of the prior art, the oxygen barrel utilized in practicing third preferred embodiment of the present invention provides a fitting or, in some examples, an integral delivery tube that allows a single delivery hose to enter the supply barrel. The delivery tube enters the oxygen delivery barrel at a point substantially aligned with the nasal septum separating the nostrils. The third preferred embodiment of the present invention therefore avoids lateral extension of delivery tubing beyond the midline of the nose and thus is highly resistant to the transfer of torsional or other displacement forces to the catheter/cannula.
As in the case of the first and second embodiment, the single midline delivery tube connected to the middle of the oxygen barrel may be affixed to the long leg by any suitable means such as, for example, a bonding agent, cement or adhesive tape. The securing means may also be selected to be retentive fabric, such as Velcro(TM), or nylon tie devices . In addition, small, pliable metal extensions may be provided upon the long leg so as to allow fixation of the delivery tubes in axial alignment with the strut. The third preferred embodiment of the present invention avoids the required ear loop of the prior art, the reduced and diminutive loop produced in utilizing the device and practicing the method of the first preferred embodiment, and the diminutive curvature associated with the second preferred embodiment herein.
As in the case of the first and second preferred embodiments above-described, above and beyond the ridge pole retainer, the delivery tubes are held together by a suitable means such as an adhesive. The may also be held together by any other suitable means such as, for example, fabric strips, adhesive tape, nylon ties or elastic bands. It is also contemplated that the delivery tubes utilized in practicing the third embodiment of the present invention may be formed together, from a point where the tubes meet and are held at the long leg of the retainer, until they junction with the oxygen supply tube. In all such embodiments, the tubing is directed over the patients forehead where it junctions with the supply tube above and behind the patient. Thus, the third preferred embodiment of the present invention, like all embodiments thereof, avoid the use of ear loops for catheter/cannula stabilization and retention.
In each of the above-described embodiments, the oxygen supply barrel may be provided as an integral part of the cannula/catheter support structure. In such cases, the barrel may be fused to the remainder of the structure, or held in place by a combination of fusion and the use of fixation xe2x80x9cfingersxe2x80x9d arising from the cup-shaped laterally extended portion and thereafter penetrating the selected barrel. In other embodiments, the barrel may be a separate and distinct component, held in position by the curved portion of the short leg as described above.
In each of the afore-mentioned embodiments of the present invention, unifying the cannula supply tubes over the long arm of the support strut reduces and or eliminates a lever arm produced by the relatively large loops formed lateral to the ends of the oxygen supply barrel by the cannula supply tubes. Avoiding and/or reducing the magnitude of these lateral loops greatly reduces the application of torsional forcesxe2x80x94applied by the these lateral cannula supply loops and initiated by head movementxe2x80x94upon the barrel. Reduction of such torsion forces upon the barrel, in turn, reduces the frequency and degree of oxygen supply nub movement and displacement. In addition, stabilizing the cannula supply line(s) via fixation to the strut obviates the need for ear loop stabilization which, as discussed above, is causative of skin fold abrasions, irritations and xe2x80x9cshaking offxe2x80x9d of cannulas during sleep.
Therefore, the present invention provides an improved catheter/cannula stabilization device and method of utilizing same demonstrating increased cannula stabilization while, at the same time, eliminating a fundamental cause of cannula loss/displacementxe2x80x94ear loop irritations/abrasionsxe2x80x94. Thus the present invention reduces the frequency of cannula loss/displacement, decreases the need for replacement of same by nursing staff, and increases patient comfort (and thus undisturbed sleep.) In view of the current nursing shortage, as well as the great expense of recruiting additional nursing staff, the reduction in need for cannula repositioning and replacement by staff, provided by the present invention, is of great economic benefit to both patients and health care facilities alike.
The first, second and third preferred embodiment of the present invention may advantageously and additionally incorporate the use of a straight edge surface, above and behind the patient""s head, and parallel to the floor. This straight edge is provided at a point behind and above the patient""s head. By running the delivery linesxe2x80x94which, in the case of paired tubes, are joined together, distal to the retainer by the means described abovexe2x80x94over the patient""s forehead and thence up and over a suitable straight edge, free movement of the tubing greatly relieves tension on the catheter/cannula during head and body movements. More specifically, the oxygen delivery tube(s), affixed along the long leg of the strut and joined to an single oxygen supply tube at or proximal to the strut, is passed directly back and across the patient""s forehead. The supply line then passes over the straight edge parallel to the floor and slightly above the patient""s head. The parallel edge allows smooth and rapid movement of the supply tube without causing any torsion or traction forces to be applied to the catheter/cannula during head movement. The straight edge utilized may be, for example, a hanger fitted to an IV stand or hospital bed. In some instances, the a headboard may provide a suitable surface. Alternatively, the tubing could pass through an elevated round loop. In certain embodiments it may be advantageous to apply a minor amount of weight, just sufficient enough to prevent tangling of the tubing on the distal side of the hole or straight edge. In this way, patient movements would not allow for the formation of tangles. However, the tension must be kept sufficiently low so as to avoid any restriction of patient head movement.
In a first alternate embodiment of the present invention, the catheter/cannula support device of the present invention can be utilized without a catheter/cannula or an oxygen source and still provide increased respiratory performance. In this embodiment, the shortening and increase in bore diameter of the external nasal passages increases breathing efficiency. This embodiment can be of great benefit to patients suffering from nasal congestion and or anatomic deformation which tend to obstruct the nasal passages. The increase in external nasal bore with a simultaneous decrease in passage length results in a significant decrease in resistance to gaseous exchange. Thus, the need for mouth breathing is reduced, respiration is facilitated and associated snoring may be eliminated. It is also believed that the reduction in breathing related stress may also reduce the risk of an untoward cardiac events.